UPDATE: One of Presbyterian Hospital’s four heart valve replacement patients died last Wednesday, contrary to a statement by Dr. Yele Aluko, the patients’ cardiologist, who said Friday that all patients were doing well. Thomas Herman Alley Jr., 89, who had the procedure Jan. 12, died six days after the procedure, and family members say he never came off life support during that time.

Minimally invasive procedure

Just as machines wear out with age, so do moving parts in the human heart.

For years, surgeons have replaced failing heart valves with artificial devices during open-heart surgery. But that requires stopping the heart and placing patients on a heart-lung bypass machine, and many are too frail to survive such drastic treatment.

Now, they have an option besides waiting to die.

With a minimally invasive procedure called transcatheter aortic valve replacement, doctors can thread an artificial valve to the heart without cracking open a patient’s chest.

“This is going to be a game changer,” said Dr. Yele Aluko, a cardiologist at Mid Carolina Cardiology in Charlotte.

In the last week and a half, Aluko has led a team of Presbyterian Hospital doctors that performed the procedure on four patients, all age 80 or older. Presbyterian is the first hospital in the Carolinas to offer the new procedure outside of clinical trials at Duke University and Wake Forest University.

Doctors at Sanger Heart & Vascular Institute have scheduled their first two patients for the procedure Wednesday at Carolinas Medical Center.

The treatment became available in November, when the Food and Drug Administration approved the Sapien artificial valve made by California-based Edwards Lifesciences. It is approved only for older, high-risk patients who cannot withstand open-heart surgery.

The study leading to FDA approval found that, despite a risk of stroke and other complications, the valve replacement procedure “significantly reduced the rates of death from any cause” for patients whose average age was 83.

Aluko and other doctors say the procedure’s significance for treating valve disease is comparable to the use of balloon angioplasty and stents as less invasive alternatives to open-heart bypass surgery for blocked arteries.

The procedure “is a transformational technology that brings hope to people that did not have a solution to their potentially lethal problem,” said Dr. Murat Tuzcu, a cardiologist at the Cleveland Clinic, which is affiliated with Presbyterian and is one of 26 medical centers that tested the Sapien device.

Common in people over 60

Heart valve disease is not as prevalent as coronary artery disease, but it is common in people over 60.

About 1.5 million Americans suffer from aortic stenosis – a narrowing of the major artery that supplies the heart and body with blood. About 500,000 have severe disease. Once symptoms occur, more than half of patients will die within two years without treatment.

“This is a very common problem as we get older,” said Dr. William Downey, a Sanger cardiologist. He said he sees about three patients a week with aortic stenosis compared to 30 a week with coronary artery disease.

“There are no medicines that can improve it,” he said. “It’s really bad and universally fatal (in a year or two) unless we replace the valve.”

In recent years, heart specialists eagerly awaited results of clinical trials the new way – implanting valves via catheters threaded through vessels, the way stents are delivered to open blockages.

The Sapien valve, made of cow tissue and polyester, is the only one approved for this use, but a second valve, made by Medtronic, is under study. Doctors at Duke and Wake Forest are participating in the latter trial and have been doing catheter-based valve replacements for about a year.

“Opening the chest is still the standard of care,” said Dr. Kevin Harrison, a cardiologist leading the Duke trial. “These valves are reserved for patients that have higher risk … and are turned down for open-heart surgery. You wouldn’t want to recommend that as a standard option for a patient that has a standard risk.”

Collaboration required

In the new procedure, the valve is compressed at the end of a catheter, slightly wider than a pencil. It’s inserted into a leg artery through a small incision in the groin. From there, the catheter is snaked to the heart, where it’s released and expanded with a balloon. The new valve replaces the body’s original, which does not have to be removed.

Patients are anesthetized during the procedure, and their hearts continue beating. Doctors monitor the catheter and valve placement using images from cardiac ultrasound and X-rays.

A team of doctors – including interventional cardiologists, heart surgeons and imaging specialists – work in a “hybrid operating room” that accommodates both cardiac catheterization and surgery. Both Presbyterian and CMC have built such rooms, at a cost of $1.5 million and $2 million, respectively.

Unlike angioplasty and stent placement, which are performed by cardiologists usually without input from surgeons, the new valve treatment requires collaboration among many specialists, Aluko said. They meet regularly to discuss cases and decide which patients are appropriate for the treatment.

“Not everybody who has aortic stenosis who is old is eligible for this,” Aluko said. “The surgeon has to say, ‘I can’t operate on you.’ ”

Risks and benefits

Despite enthusiasm among heart specialists and valve manufacturers, some doctors urge caution.

“It’s a very high-risk procedure, and it takes a lot of training,” said Dr. Rita Redberg, a cardiologist at the University of California in San Francisco. “I think we need more data on more patients and long follow-up to know truly how this is going to stack up.”

In a letter to the New England Journal of Medicine after it published results of the Sapien trial, Redberg noted the “alarmingly high percentage of patients” who had strokes after the procedure.

Redberg said it should take more than one study to get FDA approval. “It’s a very expensive device to put in,” she said. “And it’s a big device. It’s not easy to use.”

There is a risk of bleeding as the result of damage to vessels as the valve, inside a catheter, is threaded to the heart.

In the study, patients who received the valve were 2 1/2 times more likely to have a stroke and eight times more likely to have a bleeding complication than patients who didn’t.

But those who had the procedure were more likely to be alive one year later than those who didn’t. After a year, 69 percent of patients were alive compared to 50 percent of those who didn’t get the valve.

As part of approval, the FDA is requiring a registry to track patients who get the new valve. Redberg said this is important to show whether problems develop as it’s used more widely. The Sapien study involved 365 patients, but only half received the valve.

A financial analysis of the Sapien valve study suggested the total cost for transcatheter aortic valve replacement was about $80,000. Edwards Lifesciences projects U.S. sales of the device at $200 million to $260 million in 2012.

Presbyterian patient

Fred High, a retired elementary school principal from Monroe, is one of the first two Presbyterian patients who had the procedure Jan. 12.

At 80, High had been told by doctors that he was too old and sick to have open-heart surgery to replace his aortic valve. Without treatment, they said he’d probably die in a year.

Since 1996, when High had a heart attack, he said he has been “too weak to do anything.” He’s been using leg braces, a cane, a walker and a motorized scooter to get around, said Larry High, one of his three grown sons.

After the procedure, Larry High said his father looked “fantastic.”

From his hospital bed, Fred High said he looks forward to being more active. “I hope to have a better life all the way around. I want to keep up with my family. They’re young and agile.”

His wife, Wanda, said: “We’re just excited about all of this. We think he’s going to have a longer life and happier life and a better life.”

Presbyterian’s other patients declined to be identified publicly, but Aluko said they are all doing well.

The new procedure won’t replace open-heart surgery, but Aluko said it could, with further study and refinement, become available for younger patients who may be as frail.

“This is the beginning of a potential revolution in the treatment of valve disease.”

Source: charlotteobserver.com